NCT06538883
Recruiting
Not Applicable
Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial
Zhongda Hospital1 site in 1 country366 target enrollmentStarted: August 1, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Zhongda Hospital
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- The primary outcome is the rate of successful sedation without hypotension
Overview
Brief Summary
Sedatives are the mostly common prescription for patients with mechanical ventilation due to the disease or therapies.
Ciprofol is a new intravenous anesthetic agent transformed from propofol, and has a similar sedative effect of propofol in previous study.
Whether ciprofol is safe and effective similar with propofol for sedation in ICU patients with mechanical ventilation? Therefor, a multi-center, double-blind, randomized control trial was conducted with a noninferiority design, to compared the rate of successful sedation without hypotension of sedation by ciprofol or propofol in ICU patients with mechanical ventilation.
A Multi-Center, Double-Blind, Randomized Controlled Trial will be launched to evaluate the efficacy and safety of ciprofol versus propofol for sedation in ICU patients with mechanical ventilation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(patients who met all the following criteria):
- •Adults are sequentially admitted to ICU undergoing mechanical ventilation; Patients are expected to need 6-24 hours of sedation for the target RASS ranged from +1 to -2 after randomization;
- •Aged ≥ 18 and ≤ 80 years old, with no gender requirement;
- •The patients or their family members fully understood the objectives and significance of this study and voluntarily participated and signed informed consent forms.
Exclusion Criteria
- •(patients who met 1 of the following criteria were excluded):
- •1\. Patients known to be allergic or contraindicated to ciprofol.
- •BMI\<18 kg/m2 or \>30 kg/m
- •Patients who had received sedation for more than 3 days in an ICU or in a general ward prior to being transferred to the ICU before signing an informed consent form.
- •4\. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:
- •Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; patients who required vasopressor (equivalent norepinephrine ≥ 1μg/kg/min) to maintain a normal blood pressure.
- •Patients with hepatic and renal failure (liver function: refer to Child-Pugh grade C; renal function: eGFR ≤ 30 mL/(min·1.73 m2) \[eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr) - 1.234 × age - 0.179 × 0.79 (females)\]; patients undergoing dialysis.
- •Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.
- •5\. Patients with an expected survival of ≤ 24 h.
- •Pregnant or lactating females.
Arms & Interventions
Ciprofol
Experimental
Intervention: Ciprofol (Drug)
Propofol
Active Comparator
Intervention: Sedation with Propofol (Drug)
Outcomes
Primary Outcomes
The primary outcome is the rate of successful sedation without hypotension
Time Frame: within the first 30 minutes of administering the study drug
The primary outcome is the rate of successful sedation without hypotension, which have to meet the following three criteria simultaneously: 1) Sedation within the RASS target (+1 to -2); 2) No rescue therapy is used; 3) No hypotension occurs, within the first 30 minutes of administering the study drug.
Secondary Outcomes
- The 28-day mortality(from administation of study drug to 28 days)
- Incidence of hypotension(from the time of signing informed consent to 2 hours after the end of study drug administration)
- Incidence of bradycardia(from the time of signing informed consent to 2 hours after the end of study drug administration)
- Usage of study drugs(within the first 24hours of administering the study drug)
- the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;(within the first 1hour of administering the study drug)
- Extubation time(from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation)
- the rate of within sedation target (RASS: +1 to -2) without circulatory inhibition (defined as either hypotension or bradycardia) in the first 1hour of administering the study drug;(within the first 1hour of administering the study drug)
- Duration of mechanical ventilation(from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) until the date of first estubation or date of death from any cause, whichever came first, assessed up to 28 days)
- Awakening time(from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days)
- Incidence of delirium(from administation of study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days)
- Length of ICU stay(the time from ICU admission to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days)
- Duration of mechanical ventilation(from randomization until the date of first extubation or date of death from any cause, whichever came first, assessed up to 28 days)
- Extubation time(from stopping the study drug to extubation, or death from any cause, or 28 days)
- Awakening time(from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 24h after stopping the drug.)
- Length of ICU stay(the time from randomization to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days)
- The 28-day mortality(from randomization to 28 days)
- Incidence of hypotension(from randomization to 48 hours after the end of study drug administration)
- Incidence of bradycardia(from randomization to 48 hours after the end of study drug administration)
Investigators
Fei Peng
Principal Investigator
Zhongda Hospital
Study Sites (1)
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